Cancer Therapy Induced Thrombocytopenia
Conditions
Interventions
Experimental Group:Hetrombopag Olamine Tablets
Control Group:Recombinant Human Thrombopoietin Injection
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (including both ends), gender is not limited; 2. Patients with malignant tumors confirmed by tissue or cellular pathology; 3. Receiving chemotherapy in a 21-day cycle, including > = 2 chemotherapy drugs in combination therapy, or > = 1 chemotherapy drug in combination with immunotherapy and/or targeted therapy, etc., or antibody drug conjugate (ADC) single agent or in combination with other drugs; 4. Platelet count =1.0×10^9/L, and the hemoglobin (Hb) is >= 80 g/L; 7. No obvious abnormalities in liver function: for patients without liver metastases, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 50 ml/min (Cockcroft-Gault formula); 9. Estimated survival >=12 weeks, and expected to be able to be treated with the current chemotherapy regimen>=1 cycle; 10. Female subjects of childbearing potential must have a serum pregnancy test within 3 days prior to the first dose with a negative test result, and are not lactating, and must agree to use effective contraception during the trial and for 7 days after the last dose of study drug; For male subjects whose partner is a woman of childbearing potential, should be surgically sterile or must agree to use a reliable method of contraception from the time of signing the informed consent form until 7 days after the last dose of study drug. Male subjects must also agree not to donate sperm during the same time period; 11. Voluntarily join this study, sign the informed consent form, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Platelet count< 25×10^9/L; 2. In the current stage of anti-tumor therapy, the platelet count before the first chemotherapy < 75×10^9/L; 3. Accompanied by hematopoietic diseases, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.; 4. Other diseases that cause thrombocytopenia other than thrombocytopenia caused by tumor treatment (CTIT) within 6 months prior to randomization, including but not limited to chronic liver disease, hypersplenism, etc.; 5. Active infection within 2 weeks prior to randomization; 6. Tumor bone marrow invasion or bone marrow metastasis; 7. Underway/expected to receive radiotherapy involving long bones, flat bones (such as pelvis, sternum, skull, etc.); 8. Severe cardiac clinical symptoms or diseases within 6 months prior to randomization, such as New York Heart Association (NYHA) grade 3 or above heart failure, unstable angina, myocardial infarction, and clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, etc.; 9. Those who have thrombotic tendencies or are receiving thrombolysis/anticoagulation therapy; 10. Arterial or venous thrombosis events within 3 months prior to randomization, including but not limited to cerebrovascular accidents (such as transient ischemic attacks, cerebral infarctions), deep vein thrombosis and pulmonary embolism, etc.; 11. Significant clinically significant bleeding symptoms or clear bleeding tendency within 2 weeks before randomization, such as gastrointestinal or central nervous system bleeding, etc.; 12. Brain tumor or tumor brain metastases; 13. Concomitant factors affecting drug absorption (e.g., dysphagia, history of total gastrectomy surgery); 14. Complications requiring emergency treatment, such as superior vena cava syndrome, spinal cord compression, etc.; 15. Received rhIL-11, rhTPO and TPO-RA drugs (such as hetrombopag, eltrombopag, avatrombopag, etc.) within 7 days before randomization; 16. Receiving platelet transfusion within 3 days prior to randomization; 17. Patients with known or anticipated allergies or intolerances to the active ingredients or excipients of the study drug; 18. Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS); Known active viral hepatitis; 19. Participation in any other clinical study of other investigational drugs or devices within 28 days prior to randomization; 20. Subject is pregnant or is expected to become pregnant during the study treatment; 21. Other conditions that the investigator considers to have a greater risk to the health or safety of the subjects by participating in the trial, or may affect the evaluation of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of responders who meet all of the criteria during the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved a platelet count >=100 × 10^9/L within 14 days;Time from study treatment initiation to the first documented platelet response (>=100 × 10^9/L);Proportion of patients who finished the first chemotherapy cycle (C1) with platelet count >=75×10^9/L, or >=100×10^9/L at C1D21;Platelet count at each visit time point after initiation of study drug treatment;Proportion of patients who required at least one protocol-defined rescue therapy;Rate of thromboembolic events ( thromboembolic events will be graded per CTCAE);Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactLuo Suxia
Henan Cancer Hospital
Outcome results
None listed